Replies to post #650226 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Agree with this post, Lykiri. People opine with different motivations and biases. Even if they can see efficacy in the data, they turn in a blind eye. I think ultimately the data would win out. Let us hope so in the MHRA case.

[The Danish Dude]

Ah yes, they recap the nonsense of Bent and Preusser.

First your own comment Lykiri regarding these ....

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171641646

And then Al Musella debunking

I completely disagree with the paper. Luckily it was just submitted and not peer reviewed. It would never pass peer review. The easiest fact to show they are wrong is they emphasis "post-hoc" a few times. Had they read the paper, they would have seen ,,,

— Al Musella (@AlMusella) December 23, 2022

I agree completely. Did you know the novocure trials got picked apart even worse than the dcvax trials? I am a big proponent of Optune and fought against the negativity when the vast majority of clinicians were against it. There are still a few against, even after 250+ papers

— Al Musella (@AlMusella) December 23, 2022

"This is the first SAP that has been submitted for the Trial, and it is being submitted prior to Data Lock
and unblinding of the study results." The definition of "Post-Hoc" is "After the event" - which implies they saw the data before creating the SAP, and they didn't.

— Al Musella (@AlMusella) December 23, 2022

The authors want the study repeated with no crossover. I wonder if they would allow their kids or parents to participate in such a trial, with the risk of a placebo. If they wouldn't allow their family to do it, why should we.

— Al Musella (@AlMusella) December 23, 2022

Bottom Line: This study has flaws, as do ALL phase 3 trials. They are not bad enough to disregard the conclusion that DCVAX helps patients. We need to get this approved ASAP, then we will be able to experiment with combinations that will improve these already impressive results

— Al Musella (@AlMusella) December 23, 2022

I have been to many FDA meetings both public and private. I testified at the advisory committee meetings for avastin, optune and gleolan. The trials for each of these were picked apart worse than we are seeing here for dcvax. They all were approved

— Al Musella (@AlMusella) December 24, 2022

[learningcurve2020]

LOL...Another Thanksgiving gift. Can't make it up.

Bala, you hand waving clown. Wouldn't surprise me to see a JAMA retraction.

>>This exclusion (both for the placebo and the DCVax-L group) would ensure that aggressive tumors able to evade chemoradiation would not be in the trial and perhaps make OS and PFS times longer than one would expect from a general GBM population.

[meirluc]

The Ethan Chen et al. article has apparently made a monumental error in that it
stated that the 23.1 months mOS of the 331 patients cited in the 2018 JTM
article was almost 4 months longer than the 19,3 months mOS of the 232 treatment
patients in the 2022 JAMA article. The authors were apparently unaware that the
mOS results in the JTM article were measured from surgery and the mOS figures
in the JAMA publication were calculated from the time of randomization.
Bottom line: the conclusions reached in this publication do not at all change my positive
opinion concerning the immense potential of DCVax-L.

[iclight]

They understand how real trials are designed and run without changing everything post hoc. You should take note.

[flipper44]

David A Reardon must have been completely plastered when he signed onto this article. He either didn’t know the difference between time from surgery versus time from randomization or he’s…. Wait…. there is no other choice. Get that man some coffee and a cold shower. He must have been out of his mind.

[flipper44]

Worst researchers of the year award goes to:

Ethan Chen, Alexander L Ling, David A Reardon, E Antonio Chiocca

For not understanding the difference between time from surgery versus time from randomization.

[flipper44]

OMG, it was editor’s choice. So much for peer review. Why does the editorial board at SNO’s Neuro-Oncology not understand the difference between time from surgery and time from randomization? 🤠

[biosectinvestor]

Dr. Reardon seems like a TTF guy that poses as a skeptic of everything. But ultimately he seems to be TTF interested…

DCVax-L, unlike TTF, is not going to enrich these docs. Patients get the initial surgery, the vaccine is made and they can get the shots anywhere. It has low side effects and seems likely to extend life substantially with just appointments every 6 months, to check on status.

TTF requires regular appointments, tests and most likely a monthly slice of 21,000 per month from Optune, per patient, indefinitely. Patients need to be “disciplined” so it is only appropriate that the docs schedule regular check-ins to be sure they are adhering to the requirements. But as we know, their first trial showed no increase in mOS, and it literally failed but they were still approved.

This new study misstates the key details of the DCVax-L trial. They can get away with it by pretending to be “sticklers” or by saying they referenced other reports that also misstated key details. But the reality is, the treatment modality they seem most enthralled with has much more flawed data and did when they embraced it.

[meirluc]

The mOS for the placebo group was not reported because 90% of subjects crossed over from the placebo to the DCVax-L group upon determination of progression (based on MRI) from treatment.

OMG, am I right to think that this is another major confusing statement in the
Ethan Chen et al. review of the P3 trial? The above statement can be interpreted
to say that of the 99 placebos about 89 original placebo patients (90%) received DCVax-L
after their progression when in fact only 64 (64.6%) of those 99 patients were in that
category and 35 placebo patients (35.4%) never received the vaccine.

In fact, about 90% (actually 89.4%) of the 331 patients in the trial did receive DCVax-L
at some point and that included 232 who received DCVax-L before progression and 64
who received that treatment after progression. However, based on the Ethan Chen
review, I would have never reached that conclusion.

Is there any reason why this review should not be retracted?

[dstock07734]

I think they knew well about the trial data. They just don't like the fact that what they are doing is no way comparable with what DCVax-L can achieve.

Here is the clinical trial they were all involved and they just got a Nature paper published last month. Can we see the long tail in the survival curve? All patients passed away within 40 months. Did they observe high occurrence rate of pseudo progression? The current combo trial results once published will immediately make obsolete what they were doing.

https://classic.clinicaltrials.gov/ct2/show/NCT03152318?cond=NCT03152318&draw=2&rank=1

https://www.nature.com/articles/s41586-023-06623-2

[MalteseFalcon]

Reardon has ties to Nevercure.

[sentiment_stocks]

I’m not sure if it was also noted here earlier on this board that another error with this paper was the IDH mutation issue… I’m assuming that their 3rd “reason for failure” was that IDH was not noted. But many of us will remember that we waited many, many months during Covid for the company to actually obtain that data by testing the tumor tissues, and that the IDH data was given in the JAMA article. It was even noted in the TM article (the interim paper) that the company intended to obtain this data. And yet these four doctors claimed it was not given, even though the patient IDH data was provided in JAMA. From their hit piece article:

3—Reason for failure: Absence of biomarker data inhibits our understanding of the reasons behind the “tail” of long-term survivors in the trial.
Lesson learned: Need to include biomarker data via longitudinal sampling during the trial.

I knew we couldn’t trust Reardon.